Sr. Specialist, Documentation Development & Lifecycle

Job Title:     Sr. Specialist, Documentation – QC Development & Lifecycle

Location:      Columbus, OH

Job Type:     Full time

Req ID:         6902

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Sr. Specialist, Documentation – QC Development & Lifecycle to join our team.  In this role, you will be responsible for authoring quality documents for review by the appropriate customers while managing technical documentation project timelines and coordinate activities to meet the business deadlines.

 

Key Responsibilities:

• Update and maintain templates (Protocols, TR’s, JOS, Methods, Specifications, ElementaI Impurities, Residual Solvents, Nitrosamines, filing modules)
• Author technical reports from validation protocols and raw data
• Author other reports as needed, such as various risk assessments, CoAs, or stability reports
• Format of word documents, overlays
• Review data and conclusions in validation reports
• Route methods, specifications, and other documents in the quality document management systems
• Assist with gathering of filing documents for internal and external DRA
• Manage timelines and deliverables for filing document.
• As needed, support raw data review

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

 

EDUCATION

Minimum:    

• B.S. degree in a scientific discipline such as chemistry, pharmacy

Must possess a specialized knowledge of ICH and FDA guidances, technology transfer requirements, method validation, technical writing, and submission documents

 

EXPERIENCE

Minimum:    

• Five years of previous technical document experience is required. Knowledge and adherence of industry standard technical writing practices required.

• Solid understanding of FDA guidance relating to technical documentation for filing activities and laboratory practices and procedures.
• Knowledge/previous experience and understanding of scientific standards relating to creation of specifications and test results, filing procedures, template formats, and understanding of where appropriate information should be displayed in document for filing activities related to FDA submissions required.

 

Preferred Experience:  

• Experience in nasal spray dosage forms, including actuation performance tests such as pump delivery, spray content uniformity, spray pattern, plume geometry, actuation force, etc.
• Previous experience mentoring or providing training or instructions to other preferred.
• Previous method development and method validation experience preferred.

 

Skills:

• Ability to manage multiple projects.  Must be organized, detail/deadline-oriented, and possess the ability to adjust priorities to meet deadlines